Effect of Intensive Sports Practice on Lower Limb Varicose Veins

NCT02846051 | Completed DMC

• 1 other identifier: EPSI_VARISPORT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the frequency of varicose veins in the lower limbs in a population exposed to intensive sport compared to individuals matched by sex, age and body mass index (BMI) did not have an intensive sport.

Conditions

Varicose Vein

Keywords

varicose vein; physical activity

Outcome Measures

Primary Outcomes (1)

• varicose veins (C2 of the CEAP classification)

  varicose vein definition : subcutaneous vein with a diameter greater than 3 mm while standing, usually winding, the seat of pathological reflux. Varicose veins may interest saphenous trunks, their tributaries and non saphenous network. Duplex Ultrasound Investigation of the Veins in Chronic Venous Disease of the Lower Limbs-UIP Consensus Chronic venous disorders Assessment Score (Carpentier PH, Poulain C, Fabry R, Chleir F, Guias B, Bettarel-Binon C. Ascribing leg symptoms to chronic venous disorders: the construction of a diagnostic score. J Vasc Surg Off Publ Soc Vasc Surg Int Soc Cardiovasc Surg North Am Chapter. nov 2007;46(5):991- 6.)

  3 years

Secondary Outcomes (2)

• lower limb vein calibers

  3 years

• venous reflux

  3 years

Study Arms (2)

intensive sport practice

OTHER

intensive sport practice 1. the subject must practice for more than six months a drive of at least 8 hours / week, intense, above the ventilatory threshold, or 60-70% of maximum consumption oxygen or 70-80% of maximum heart rate, ie beyond a moderate slowdown. If stopping the intensive sport practice, the duration of the stop at the time of the study should be less practice time. 2. volunteers, 3. from 18 to 80 years, 4. free to consent. 5. covered by social security. 6. reported in the national register of healthy volunteers. The intervention is a lower limb venous examination = venous mapping

Procedure: venous mapping

control group

OTHER

\&) Volunteers who do not have intensive sport practice as it is defined in the group "intensive sport practice" 2) from 18 to 80 years, 3) free to consent. 4) covered by social security. 5) reported in the national register of healthy volunteers. The intervention is a lower limb venous examination = venous mapping

Procedure: venous mapping

Interventions

venous mapping PROCEDURE

clinical examination + doppler echo

control group; intensive sport practice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers
• From 18 to 80 years
• Free to consent
• Covered by social security
• Reported in the national register of healthy volunteers

You may not qualify if:

• Signed Refusal of the consent form .
• Refusal to be registered with the National File Healthy Volunteers.
• Under guardianship
• Inability of the subject to hold long enough in standing position (20 minutes) for practicing phlebology examination.

Sponsors & Collaborators

• University of Franche-Comté: lead

Study Sites (1)

Beliard

Besançon, 25000, France

Location

MeSH Terms

Conditions

Varicose Veins; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Nicolas Tordi, PU

  Equipe d'Accueil 4267 : Fonctions et dysfonctions épithéliales Université de Franche Comté

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MCU-HDR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 27, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)